8 General Notices/Errata

GENERAL NOTICES/ERRATA

Vol. 33 Iss. 2 - September 19, 2016

DEPARTMENT OF AGRICULTURE AND CONSUMER SERVICES

2016 Annual Report - Agricultural Stewardship Act

The Commissioner of Agriculture and Consumer Services announces the availability of the annual report of the Agricultural Stewardship Act entitled "Agricultural Stewardship Act Annual Report, April 1, 2015 – March 31, 2016." Copies of this report can be obtained by contacting Joyce Knight at telephone, [phone] or via email at [e-mail]. The report can also be obtained by accessing the Virginia Department of Agriculture and Consumer Services website at http://www.vdacs.virginia.gov/conservation-and-environmental-agricultural-stewardship.shtml. A written request may be sent to the address below. Copies of the report are available without charge.

Department of Agriculture and Consumer Services
Office of Policy, Planning, and Research
P. O. Box 1163
Richmond, VA 23218

Questions regarding the report may be directed to the contact listed above.

DEPARTMENT OF ENVIRONMENTAL QUALITY

Civil Enforcement Manual

Purpose of notice: To announce an opportunity for public comment on the Department of Environmental Quality's Civil Enforcement Manual.

Revised public comment period: August 22, 2016, through October 21, 2016

Topic of public comment: The Department of Environmental Quality (DEQ) is providing an opportunity for the public to comment on draft, revised guidance used in its enforcement program. The draft, revised guidance addresses the procedures that DEQ staff use to resolve and prioritize alleged violations of environmental requirements and how to calculate appropriate civil charges and civil penalties in administrative enforcement actions for DEQ's air stationary source program, land protection and remediation programs, and water programs. Once final, the draft, revised guidance will supersede the current Chapters 2 through 4 of the DEQ Civil Enforcement Manual (Virginia Regulatory Town Hall ID: CEM-03, CEM-04, CEM-06, CEM-07, CEM-07A, and CEM- 07BMemo).

The draft text can be found at http://www.deq.virginia.gov/Programs/Enforcement
/PublicNotices.aspx. Comments can be emailed to Lee Crowell at [e-mail].

Proposed Environmental Remedy for Intermet Archer Creek Foundry

Date of this notice: September 18, 2016

Purpose of this notice: The Virginia Department of Environmental Quality (DEQ) is announcing its proposed remedy for the Intermet Archer Creek Foundry located in Lynchburg, Virginia, under the Resource Conservation and Recovery Act (RCRA), as amended, 42 USC §§ 6901 through 6939(e). DEQ's proposed remedy consists of implementation and maintenance of institutional controls and engineering controls to protect human health and the environment.

Facility description: The 193-acre facility was a small castings foundry that manufactured metal parts for automobiles, heavy trucks, small internal combustion engines, computers, industrial tools, and household appliances. The facility (also known as Archer Creek Foundry) was owned by Intermet Corporation from 1973 to 2009 when operations ceased, then sold to Virginia Casting Industries in 2010. The facility managed hazardous and nonhazardous wastes and completed numerous cleanup activities since 1998. Currently, the property consists of large concrete pads delineating the footprint of former structures, several derelict structures, a closed solid waste landfill, and elements of a former wastewater treatment system.

Information availability: A statement of basis for the proposed remedy is available on DEQ's website at http://www.deq.virginia.gov/Programs
/LandProtectionRevitalization/PublicNotices.aspx.

The Administrative Record, which contains information considered in DEQ's proposed remedy, is available for public review at Virginia Department of Environmental Quality Central Office, 629 East Main Street, Richmond, VA 23219, during office hours, Monday through Friday, 8 a.m. to 5 p.m. For additional information, contact Brett Fisher, Corrective Action Project Manager, at the address listed above; telephone [phone], FAX [phone], or email [e-mail].

Comment process: Persons wishing to comment on DEQ's proposed remedy must submit comments to DEQ within the 30-day comment period ending October 18, 2016. Interested persons may also request a public meeting on this proposed remedy. All comments or requests for a meeting must be submitted in writing via mail, fax, or email to the DEQ project manager, Brett Fisher, as listed above, and must be received prior to October 18, 2016. All comments will be considered in making a final decision.

Final decision: DEQ will make a final decision after considering all comments, consistent with applicable RCRA requirements and regulations. If the decision is substantially unchanged from the one in this notice, DEQ will issue a final decision and inform all persons who submitted written comments or requested notice of DEQ's final determination. If the final decision is significantly different from the one proposed, DEQ will issue a public notice explaining the new decision and will reopen the comment period.

STATE BOARD OF HEALTH

Notice of Periodic Review and Small Business Impact Review

Pursuant to Executive Order 17 (2014) and §§ 2.2-4007.1 and 2.2-4017 of the Code of Virginia, the Department of Health is conducting a periodic review and small business impact review of 12VAC5-630, Private Well Regulations. The review of this regulation will be guided by the principles in Executive Order 17 (2014).

The purpose of this review is to determine whether this regulation should be repealed, amended, or retained in its current form. Public comment is sought on the review of any issue relating to this regulation, including whether the regulation (i) is necessary for the protection of public health, safety, and welfare or for the economical performance of important governmental functions; (ii) minimizes the economic impact on small businesses in a manner consistent with the stated objectives of applicable law; and (iii) is clearly written and easily understandable.

The comment period begins September 19, 2016, and ends October 10, 2016.

Comments may be submitted online to the Virginia Regulatory Town Hall at http://www.townhall.virginia.gov/L/Forums.cfm. Comments may also be sent to Dwayne Roadcap, Division Director, Onsite Sewage, Water Services, Environmental Engineering and Marina Programs, Virginia Department of Health, 109 Governor Street, Richmond, VA 23219, telephone [phone], FAX [phone], or email [e-mail].

Comments must include the commenter's name and address (physical or email) information in order to receive a response to the comment from the agency. Following the close of the public comment period, a report of both reviews will be posted on the Town Hall and a report of the small business impact review will be published in the Virginia Register of Regulations.

DEPARTMENT OF MEDICAL ASSISTANCE SERVICES

Draft Provider Access Monitoring Plan

Notice is hereby given that the Department of Medical Assistance Services (DMAS) is publishing for public comment the agency's Draft Provider Access Monitoring Plan as required by the Final Provider Access Monitoring Rule found in 42 CFR 447.203.

Comments or inquiries may be submitted through September 29, 2016, in writing, to Brian McCormick at email [e-mail]. Comments are available for review at http://townhall.virginia.gov/L/comments.cfm?GeneralNoticeid=628. The full text of the report may be found at the top of the "What's New" section on the right hand side of the DMAS website at http://www.dmas.virginia.gov.

Virginia Access Monitoring Review Plan Overview

In November 2015, the Centers for Medicare and Medicaid Services (CMS) issued a final rule regarding member access to Medicaid services in a Medicaid fee-for-service (FFS) environment. This rule creates new requirements for states to monitor access to care for Medicaid FFS members. Under these requirements, states must develop an access monitoring review plan, which must be published for public review and comment and submitted to CMS. In accordance with these requirements, the Virginia DMAS has prepared the access monitoring review plan.

The Virginia Medicaid program provides health care coverage for low-income individuals, including children, pregnant women, individuals with disabilities, the elderly, parents, and other adults. DMAS is the single state agency that administers the Medicaid program in the Commonwealth of Virginia. The mission of the Virginia Medicaid program is to provide access to a comprehensive system of high quality and cost effective health care services to qualifying Virginians.

DMAS provides Medicaid coverage to individuals through managed care and fee-for-service delivery models. The managed care delivery system, known as Medallion 3.0., covers Medicaid members through six commercial health plans. Virginia has been increasing its use of the managed care program, and as of December 2015, over 68% of Medicaid enrollees are in managed care. During state fiscal year (SFY) 2015, the Virginia Medicaid program provided coverage to approximately 1.35 million enrolled members, and total Medicaid spending was approximately $7.9 billion.

Virginia has a population of 8.4 million people, making it the 12th most populous state in the United States. With 98 acute care hospitals and affiliated practices and a network of 130 federally qualified health center and rural health clinic sites, there are numerous options for Medicaid members to receive health care services.

Virginia is committed to ensuring its enrolled members have adequate access to health care services. A key component of DMAS' strategic plan is ensuring adequate provider network access by monitoring and analyzing utilization, provider caseloads, reimbursement rates, and Medicaid population groups. The state has conducted other studies on member access to health care services, including a 2013 study by the Joint Legislative Audit and Review Commission, and on health care access to ensure that its Medicaid FFS members have access to care that is comparable to the general population. The methodology employed in this plan will consist of evaluating trends in provider availability and participation in the Medicaid program, trends in utilization of services by Medicaid members, and member and provider feedback.

Using the metrics and data sources described in this plan, DMAS will measure and monitor indicators of health care access to ensure that its Medicaid FFS members have access to care that is comparable to the general population. The methodology employed in this plan will consist of evaluating trends in provider availability and participation in the Medicaid program, trends in utilization of services by Medicaid members, and member and provider feedback. Through the FFS monitoring plan and subsequent updates to the plan, DMAS anticipates that the access monitoring analysis, metrics, data sources, and other factors will evolve over time. Separate access monitoring and provider network sufficiency requirements are present in a managed care environment and under home and community-based services waiver programs, and these issues are not addressed in this plan.

Because members located in different areas may have different experiences accessing health care services, this plan will analyze access to care by geographic region. Specifically, the plan will analyze access to care for the regions utilized by the Virginia Medicaid program for Managed Long-term Supports and Services and the managed care program, Medallion 3.0.

In accordance with 42 CFR 447.203, Virginia developed this access monitoring review plan for the following service categories provided under a FFS arrangement:

• Primary care services

• Physician specialist services

• Behavioral health services

• Pre-natal and post-natal obstetric services, including labor and delivery

• Home health services

The plan describes data that will be used to measure access to care for members in FFS. The plan considers the availability of Medicaid providers, utilization of Medicaid services and the extent to which Medicaid members' health care needs are fully met. The plan was developed during the months of July and August 2016 and posted on the Virginia Regulatory Town Hall website under General Notices, found at the following address: http://townhall.virginia.gov/L/EditNotice.cfm?GNid=new from August 28, 2016, to September 29, 2016, as well as posted on the DMAS website at http://www.dmas.virginia.gov to allow for public inspection and feedback.

Contact Information: Emily McClellan, Regulatory Manager, Division of Policy and Research, 600 East Broad Street, Suite 1300, Richmond, VA 23219, telephone [phone], FAX [phone], TDD [phone], or email [e-mail].

Notice of Intent to Change the Reimbursement Methodology for Pharmacy Services

Notice is hereby given that the Department of Medical Assistance Services (DMAS) intends to change the reimbursement methodology for pharmacy services pursuant to the department's authority under Title XIX of the Social Security Act. This notice is intended to satisfy the requirements of 42 CFR 447.205 and of § 1902(a)(13) of the Social Security Act, 42 USC § 1396a(a)(13).

A copy of this notice is available for public review from Donna Proffitt, Manager, Pharmacy Services, Division of Health Care Services, Department of Medical Assistance Services, 600 Broad Street, Suite 1300, Richmond, VA 23219.

DMAS is specifically soliciting input from stakeholders, providers, and beneficiaries on the potential impact of the proposed reimbursement adjustments to pharmacy services. Comments or inquiries may be submitted, in writing, through September 29, 2016, to Ms. Proffitt at [e-mail], and such comments are available for review at http://townhall.virginia.gov/L/ViewNotice.cfm?gnid=623. Comments may also be submitted, in writing, on the Regulatory Town Hall public comment forum at http://townhall.virginia.gov.

This notice is available for public review on the Regulatory Town Hall, on the General Notices page at https://townhall.virginia.gov/L/generalnotice.cfm.

DMAS is making these changes in its methods and standards for setting payment rates for services in order to comply with the legislative mandates set forth in Item 306 of Chapter 780 of the 2016 Acts of Assembly.

In order to comply with a new requirements in a final federal rule entitled "Medicaid Program; Covered Outpatient Drugs" that was published in the Federal Register on February 1, 2016, DMAS proposes the following new payment methodology for pharmacy services effective December 1, 2016:

A. Payment for covered outpatient legend and nonlegend drugs dispensed by a retail community pharmacy will include the drug ingredient cost plus a $10.65 professional dispensing. The drug ingredient cost reimbursement shall be the lowest of:

1) The national average drug acquisition cost (NADAC) of the drug;

2) When no NADAC is available, DMAS shall reimburse at wholesale acquisition cost (WAC) + 0%; or

3) The federal upper limit (FUL); or

4) The provider's usual and customary (U & C) charge to the public, as identified by the claim charge.

B. Payment for specialty drugs not dispensed by a retail community pharmacy but dispensed primarily through the mail will include the drug ingredient cost plus a $10.65 professional dispensing. The drug ingredient cost reimbursement shall be the lowest of:

1) The national average drug acquisition cost (NADAC) of the drug;

2) When no NADAC is available, DMAS shall reimburse at wholesale acquisition cost (WAC) + 0%; or

3) The federal upper limit (FUL); or

4) The provider's usual and customary (U & C) charge to the public, as identified by the claim charge.

C. Payment for drugs not dispensed by a retail community pharmacy (i.e., institutional or long-term care facility pharmacies) will include the drug ingredient cost plus a $10.65 professional dispensing. The drug ingredient cost reimbursement shall be the lowest of:

1) The national average drug acquisition cost (NADAC) of the drug;

2) When no NADAC is available, DMAS shall reimburse at wholesale acquisition cost (WAC) + 0%; or

3) The federal upper limit (FUL); or

4) The provider's usual and customary (U & C) charge to the public, as identified by the claim charge.

D. Payment for clotting factor from specialty pharmacies, hemophilia treatment centers (HTC) and centers of excellence will include the drug ingredient cost plus a $10.65 professional dispensing. The drug ingredient cost reimbursement shall be the lowest of:

1) The national average drug acquisition cost (NADAC) of the drug;

2) When no NADAC is available, DMAS shall reimburse at wholesale acquisition cost (WAC) + 0%; or

3) The provider's usual and customary (U & C) charge to the public, as identified by the claim charge.

E. (1) 340B covered entities and federally qualified health centers (FQHCs) that fill Medicaid member prescriptions with drugs purchased at the prices authorized under § 340B of the Public Health Services Act will be reimbursed no more than the actual acquisition cost for the drug plus a $10.65 professional dispensing fee. Section 340B-covered entities that fill Medicaid member prescriptions with drugs not purchased under the § 340B of the Public Health Services Act will be reimbursed in accordance to § 7.1 plus the $10.65 professional dispensing fee as described in § 7.8.

(2) Drugs acquired through the federal § 340B drug price program and dispensed by § 340B contract pharmacies are not covered.

F. Facilities purchasing drugs through the federal supply scheduled (FSS) or drug pricing program under 38 USC § 1826, 42 USC § 256b, or 42 USC § 1396-8, other than the § 340B drug pricing program will be reimbursed no more than the actual acquisition cost for the drug plus a $10.65 professional dispensing fee. Nominal price as defined in 42 CFR 447.502 means a price that is less than 10% of the average manufacturer price (AMP) in the same quarter for which the AMP is computed.

G. Payment for pharmacy services will be as described in §§ 7.1 - 7.7; however, payment shall include the allowed cost of the drug plus only one professional dispensing fee, as defined at 42 CFR 447.502, per month for each specific drug. Exceptions to the monthly dispensing fees shall be allowed for drugs determined by the department to have unique dispensing requirements. The professional dispensing fee for all covered outpatient drugs shall be $10.65. The professional dispensing fee shall be determined by a cost of dispensing survey conducted at least every five years.

H. Physician administered drugs (PADs) submitted under the medical benefit will be reimbursed at 106% of the average sales price (ASP). PADs without an ASP on the Centers for Medicare and Medicaid Services reference file will be reimbursed at the provider's acquisition cost. Covered entities using drugs purchased at the prices authorized under § 340 B of the Public Health Services Act for Medicaid members must bill Medicaid their actual acquisition cost (AAC).

I. Payment dispensed to Indian Health Service, tribal, and urban Indian pharmacies. DMAS does not have any Indian Health Service, tribal, or urban Indian pharmacies enrolled at this time. Payment for pharmacy services will be defined in a state plan amendment if such entity enrolls with DMAS.

J. Investigational drugs are not a covered service under the DMAS pharmacy program.

Contact Information: Emily McClellan, Regulatory Manager, Division of Policy and Research, Department of Medical Assistance Services, 600 East Broad Street, Suite 1300, Richmond, VA 23219, telephone [phone], FAX [phone], TDD [phone], or email [e-mail].

STATE WATER CONTROL BOARD

Proposed Consent Special Order for Crossroads Holdings, LLC

An enforcement action has been proposed for Crossroads Holdings, LLC for violations at Crossroads Quicklane in Prince George, Virginia. The State Water Control Board proposes to issue a special order by consent to Crossroads Holdings, LLC to address noncompliance with the State Water Control Law and regulations. A description of the proposed action is available at the Department of Environmental Quality office named below or online at www.deq.virginia.gov. Carla Pool will accept comments by email at [e-mail], FAX at [phone], or postal mail at Department of Environmental Quality, Central Office, P.O. Box 1105, Richmond, VA 23218, from September 19, 2016, to October 19, 2016.

Total Maximum Daily Load for Woods Creek

Committee meeting: A community meeting will be held Wednesday, October 5, 2016, at 6:30 p.m. at Maury River Middle School. This meeting will be open to the public and all are welcome. In the case of inclement weather, the meeting will be postponed until Tuesday, October 11, 2016, at 6:30 p.m. For more information, please contact Tara Sieber at email [e-mail] or telephone at [phone].

Purpose of notice: The Department of Environmental Quality (DEQ) and its contractor, Virginia Tech's Biological Systems Engineering Department, will discuss population data for the development of a water quality study known as a total maximum daily load (TMDL) for Woods Creek. This is an opportunity for local residents to learn about the condition of this stream, share information about the area, and become involved in the process of local water quality improvement. A public comment period will follow the meeting (October 5, 2016, through November 7, 2016).

Meeting description: A public meeting will be held to introduce to the local community the water quality improvement process in Virginia, known as the TMDL process, invite their participation and solicit their contributions, showcase the water quality studies done by local school students, and review next steps. Section 303(d) of the Clean Water Act and § 62.1-44.19:7 C of the Code of Virginia require DEQ to develop TMDLs for pollutants responsible for each impaired water contained in Virginia's § 303(d) TMDL Priority List and Report.

Description of study: Woods Creek does not meet water quality standards for recreation due to an excess of bacteria. In addition, this stream does not host a healthy and diverse population of aquatic life and subsequently was listed as impaired for the "General Benthic (Aquatic life)" water quality standards. The bacteria standard preserves the "Primary Contact (recreational or swimming)" designated use for Virginia waterways. Excessive bacteria levels may pose a threat to human health. This water quality study reports on the sources of bacterial contamination and recommends reductions to meet TMDLs for the impaired waters. A TMDL is the total amount of a pollutant a water body can contain and still meet water quality standards. To restore water quality, bacterial levels need to be reduced to the TMDL amount. Virginia agencies are working to identify sources of bacteria and will determine the pollutant cause of the benthic impairments as well as identify sources of this pollutant through a weight of evidence approach. Reductions and a TMDL for the cause of the impairment will be developed.

Stream	County	Impairment
Woods Creek	Lexington and Rockbridge County	Bacteria, Aquatic Life

How to comment and participate: The meetings of the TMDL process are open to the public, and all interested parties are welcome. Written comments will be accepted through November 7, 2016, and should include the name, address, and telephone number of the person submitting the comments. For more information or to submit written comments, please contact Tara Sieber, Department of Environmental Quality, Valley Regional Office, P.O. Box 3000, Harrisonburg, VA 22801, telephone [phone], FAX [phone], or email [e-mail].

VIRGINIA CODE COMMISSION

Notice to State Agencies

Contact Information: Mailing Address: Virginia Code Commission, General Assembly Building, 201 North 9th Street, 2nd Floor, Richmond, VA 23219; Telephone: Voice [phone]; Email: [e-mail].

Meeting Notices: Section 2.2-3707 C of the Code of Virginia requires state agencies to post meeting notices on their websites and on the Commonwealth Calendar at http://www.virginia.gov/connect/commonwealth-calendar.

Cumulative Table of Virginia Administrative Code Sections Adopted, Amended, or Repealed: A table listing regulation sections that have been amended, added, or repealed in the Virginia Register of Regulations since the regulations were originally published or last supplemented in the print version of the Virginia Administrative Code is available at http://register.dls.virginia.gov/documents/cumultab.pdf.

Filing Material for Publication in the Virginia Register of Regulations: Agencies use the Regulation Information System (RIS) to file regulations and related items for publication in the Virginia Register of Regulations. The Registrar's office works closely with the Department of Planning and Budget (DPB) to coordinate the system with the Virginia Regulatory Town Hall. RIS and Town Hall complement and enhance one another by sharing pertinent regulatory information.

ERRATA

STATE BOARD OF HEALTH

Notice of Update to Internet Address in Virginia Administrative Code

Pursuant to 1VAC7-10-60, the Registrar of Regulations has updated an invalid Internet address in the Virginia Administrative Code as follows:

Title of Regulation: 12VAC5-195. Virginia WIC Program.

Correction to 12VAC5-195-680 D:

At the end of 12VAC5-195-680 D, replace the Internet address with the following:
http://www.vdh.virginia.gov/livewell/programs/wic/content
/retailers/documents/UPCUpdateRequestForm.pdf.

Contact Information: Susan Puglisi, Policy Analyst, Office of Family Health Services, Virginia Department of Health, 109 Governor Street, Richmond, VA 23219, telephone [phone], or email [e-mail].

BOARD OF HISTORIC RESOURCES

Title of Regulation: 17VAC5-20. Regulations Governing Permits for the Archaeological Removal of Human Remains.

Publication: 32:25 VA.R. 3424-3428 August 8, 2016

Correction to Final Regulation:

Page 3424, column 1, Effective Date, change "September 20, 2016" to "September 8, 2016"

VA.R. Doc. No. R14-3990; Filed September 8, 2016, 8:58 a.m.